FDA Device Recall Z-2102-2025

Intersurgical Inc · East Syracuse, NY

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.

Lot / serial / GTIN: Model Number: 8008000. UDI-DI (Case): 05030267166497. UDI-DI (Single Unit): 5030267150649. Lot Numbers: 1240555, 1240793.

Quantity: 2,152 pieces

Reason for recall

Potential for faulty devices as a result of depleted batteries.

Recall record

Recall number: Z-2102-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US distribution AZ, CA, FL, GA, IL, IN, KS, MD, MI, MO, NV, NY, OH, PA, SC, TX, VA.
Recall initiated: 2025-06-17
Classified by FDA Center: 2025-07-11
FDA published: 2025-07-23
Recalling firm: Intersurgical Inc
Firm location: East Syracuse, NY

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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